Category: Rules and Regulations

  • Schedule H : List of Prescription Drugs

    Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule H: Schedule H includes drugs that shall be sold by retailer on prescription of the registered medical practitioners. Labeling Requirements: If product contains a substance specified in Schedule H be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following…

  • List of Schedule H1 Drugs. Difference between Schedule H and Schedule H1

    Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Topic Covered Under Article: Related: List of Schedule H drugs What are the Schedule H1 Drugs? Schedule H1 is a subcategory of Schedule H of the Drugs and Cosmetics Rules, 1945, which regulates the sale and distribution of prescription drugs in India. The aim of Schedule H1 is to curb the indiscriminate use of antibiotics…

  • Meaning of IP/BP/USP | Licenses Required For Selling Over the Counter Products

    Query: We are into Processed Food product business and operating under private our private brand. Now we are looking to foray into OTC-Healthcare segment specifically with Antacids, Pain Relievers Gel/Spray & Vitamin tablet. So going through internet for a query whether Above mentioned products requires any type of wholesale allopathy drug license because we want…

  • Schedule C and C1 Drugs List

    Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z What is Schedule C and C1 Drugs? Schedule C and C1 drugs includes biological and special products. Schedule C and C1 under drug and cosmetic act & rules covers generally serum, hormones, vaccines, toxins, anti toxins and other biological and special products. For manufacturing for sale and distribution of Schedule C and C(1) drugs,…

  • National List of Essential Medicines (NLEM) 2022

    Alphabetical List of Medicines in NLEM 2022 5-aminosalicylic acid (Mesalazine/Mesalaine) 5-Fluorouracil 6-Mercaptopurine Abacavir Abacavir (A) + Lamivudine (B) Acetazolamide Acetylsalicylic acid Actinomycin D Activated Charcoal Acyclovir Adenosine Adrenaline Albendazole Allopurinol All-trans retinoic acid Alprostadil Amikacin Amiodarone Amitriptyline Amlodipine Amoxicillin Amoxicillin (A) + Clavulanic acid (B) Amphotericin Ba) Amphotericin B (conventional)b) Lipid Amphotericin Bc) Liposomal Amphotericin…

  • Do will Require Drug License for B2B Medicine Sale?

    Query: We are a trading firm and now started to deal in the medicine area. It says we need to have a drug license but as we are B2B traders. We have registered a business at a residential address. For medicines also we need to be directly exporting from the vendor’s location. We are not…

  • What are Drug and Cosmetic Act, 1940 & Rules, 1945?

    The Drug and cosmetic Act, 1940 is an act to regulate import, manufacture, distribution & sale of drug and cosmetics.  The Drug and Cosmetic rules, 1945 made under the act prescribe statuary requirements for grant of license to manufacture for sale and distribution of drug to ensure safety, efficacy and quality of drugs manufactured and…

  • Steps involved to register the herbal medicine

    Query: This is with regards to the herbal products and registration. I would like to know to steps involved to register the herbal medicine. Response: Herbal Medicines and Ayurvedic Medicines are synonyms in Indian Market. Herbal Medicines are manufactured by same way and under same manufacturing license as of Ayurvedic Medicines. Herbal Medicines could be…

  • Renewal Omitted: No Need for Renewal of Pharmaceutical Drug Licences and its Effect

    With effect from new amendment in Drug and Cosmetic Act, 1945, you will not need for renewal of your drug license in future. If you have Retail/Pharmacy, Wholesale/Distribution, Loan or Manufacturing License Form* for pharmaceutical and cosmetic preparations then you will have no need to renew it. You only need to deposit license retention fee…

  • How many years the Schedule H1 Medicines Record To Be Kept Stored

    Query: I have some queries 1. What are the details of a patient and doctors has to be noted and to be keep in record ? If possible please attache specimen sample2. For How many years the Schedule H1 Medicines Record To Be Kept Stored?3. Is only purchase bill of schedule H1 drugs is to…